WOMEN'S MENTAL HEALTH AND SEX/GENDER DIFFERENCES RESEARCH RELEASE DATE: June 20, 2003 PA NUMBER: PA-03-143 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Replacement R01 (PA-06-333) and R21 (PA-06-334) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE: April 1, 2006 National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.242 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This PA replaces PA-00-074. The National Institute of Mental Health (NIMH) invites research grant applications on women's mental health and sex/gender differences in mental health across the lifespan. The overall prevalence of mental disorders does not differ between the sexes, but females and males differ in the prevalence and clinical course of specific disorders. Starting in childhood, females have twice the incidence of anxiety disorders as do males, who have three times the incidence of autism and attention deficit disorder. After puberty, females report twice the incidence of depressive disorders and eight to ten times the incidence of eating disorders as do males, who report twice the incidence of substance use disorders. For other serious mental disorders, such as schizophrenia and bipolar disorder, gender disparities in incidence are not found. However, significant differences in clinical course have been demonstrated across the lifespan. This pattern of disparities in the epidemiology of mental disorders in males and females provides indirect evidence of hormonal, biological, social, cultural and developmental factors in etiology and course. An increasing body of basic and clinical research also provides evidence of neurobiological sex differences that may predispose to clinical differences in mental disorders. The finding of sex/gender differences in epidemiological, basic, and clinical studies has also increased interest in the application of that knowledge to improving interventions and services for males and females. In recognition of the importance of studying sex/gender differences in health outcomes, NIH has provided guidelines to researchers for inclusion of women and men in clinical research and for gender analysis of clinical trials outcomes. Through research such as that called for in this PA, NIMH seeks to increase the understanding of the significance of sex/gender differences in mental health outcomes and to assess their significance for mental health prevention, treatment and services. RESEARCH OBJECTIVES In April 2001, the Institute of Medicine issued a report entitled "Exploring the Biological Contributions to Human Health: Does Sex Matter?" In order to improve conceptual research models, the report recommended greater precision in terminology used to refer to findings from studies comparing health outcomes in males and females. Therefore, in this PA, the term "sex difference" is used to refer to primarily biological variables and the term "gender difference" is used to refer to psychosocial and cultural variables. Nonetheless, it is recognized that this distinction is often not clear-cut in the area of brain research, where it has been demonstrated that experience can modify brain structure and function. This program announcement identifies three major areas for research emphasis: basic and clinical neuroscience; epidemiology and risk factors; and intervention and services research. 1) Basic and Clinical Neuroscience - There is increasing evidence that neurobiological sex differences impact a wide array of behaviors and may alter vulnerability to different mental disorders, severity of course, and/or response to different treatments. Basic studies in animals and humans as well as human clinical studies in subjects with mental disorders are appropriate for developing knowledge of the processes responsible for these sex differences. Examples of research areas include studies of: o Sex differences in brain processes contributing to behavior as determined by structural and functional brain imaging of normative and clinical populations. o Sex differences in the molecular and cellular bases of behavior, including neurotransmitter and peptide signaling, synaptic plasticity, neurogenesis, and regulation of neural circuitry regulating cognition and mood. o Sex differences in gene regulatory factors and gene-environment interactions contributing to mental disorders. o Sex differences in the developmental-organizing and activating influences of sex steroids on brain and behavior and their interactions with thyroid- and hypothalamic-pituitary adrenal axes, the neuroimmune system, and neurotransmitters and peptides in brain. o Sex differences and sex hormone influences on the pharmacokinetics, pharmacodynamics and pharmacogenetics of psychotropic medications o Development of models to examine the impact of hormonal transitions across the lifespan on brain function, including, for example, brain plasticity, cognition, and mood Evidence suggests that sex differences in hormone actions contribute to differences in physiological and behavioral responses to stress. There are also sex/gender differences in the types of stressors an individual is likely to be exposed to. For example, epidemiological studies show that females are more likely to have experienced early childhood sexual abuse, a severe stress with potential long-term impact on stress responsiveness. To understand this complex area, multi-disciplinary approaches are required, ranging from basic research models in animals and humans to clinical research in children, adults, and the elderly. Examples of relevant research areas include: o Examination of brain mechanisms mediating sex differences in the impact of stress on appetite, aggression, cognition, exploration, sleep, energy, mood, biological rhythms, and susceptibility to mental disorders o Elucidation of how biological sex impacts developmental mechanisms determining susceptibility to adverse consequences of stress and risk for mental disorders throughout life. 2) Epidemiology and Risk Factors - During the past two decades, advances in diagnosis and in survey methodologies have enabled researchers to establish general estimates of the impact of mental disorders in women and men and their intervention and service needs. This work remains to be done for children and adolescents. The need for such research is particularly pressing, because in many disorders, gender differences emerge first in adolescence when early intervention strategies may be most effective in preventing full-blown mental disorders. There is also relatively little information about the influence of gender-related or gender-specific factors on such important clinical aspects of mental disorders as risk for recurrence, chronicity, comorbidity and disability in later life. Studies to further elucidate the role of gender-related or gender-specific factors in diagnosis, epidemiology, risk for onset or recurrence, and in the course of mental disorders across the lifespan are needed. Examples of relevant research areas include: o Elucidation of disparities in prevalence of mental illness and related disability, and in access to care among women and girls of different ethnic and socioeconomic backgrounds. o Assessment of the reliability, validity and predictive value of approaches to conceptualizing and measuring psychopathology in female populations. o Identification of demographic variables and social, cultural, and environmental factors related to gender differences in mental disorders (e.g., work and family roles, marriage, gender discrimination, response to psychosocial stressors, propensity to use substances). o Elucidation of childhood risk and protective factors related to the emergence of gender disparities in incidence and course of mental disorders (particularly mood, anxiety, and eating disorders). The following lifespan developmental issues are of interest: o The roles of hormonal, genetic, and social factors in the emergence of sex/gender differences in susceptibility to mental disorders, mood, and cognitive disruption during defined transitional periods including puberty, pregnancy, the postpartum period, and perimenopause. 3) Intervention and Services Research - There are an increasing number of findings indicating sex/gender differences in response to interventions as well as in preferences for different kinds of services and interventions. Additionally, women's social roles and reproductive status raise special issues related to choices of treatments and services. Interventions are defined here to include preventive, treatment, services-system and rehabilitative strategies at the individual, provider, organizational and systems levels. There is a need to incorporate consideration of such issues in the design and analysis of outcomes in mental health research. Examples of relevant research areas include studies of: o Sex/gender differences in acute and maintenance treatment outcomes for mental disorders and suicidal behaviors. o Sex/gender differences in treatment adherence and side effects of treatments and in treatment preferences, expectancies, provider behaviors, and services use. o Drug-drug interactions (e.g., supplements, replacement hormones, and psychotropic and other medications) in females across the life span. o Strategies for early detection of precursors to depression, anxiety, eating disorders, suicidality, and other behavioral disorders in female children and adolescents; the development of interventions targeting these manifestations; and the development of effective mechanisms for successful referral and adherence to treatment. o Interventions aimed at improving outcomes in women and girls at risk for mental disorders or diagnosed with mental disorders comorbid with other disorders (e.g., anxiety disorders in depression; substance abuse in women with bipolar disorder or schizophrenia, depression, and medical illness). o Preventive interventions for mental disorders with female-specific risk factors (e.g., stressors in caregiver roles, etc.). o Taxonomies of functional outcomes and disabilities in women and girls with mental disorders and instruments to measure functional changes following interventions. o Screening and identification of women with mental disorders and of women who are at high risk for the development of such disorders in general medical settings and in non-traditional settings, with the development of effective strategies for referral and treatment. MECHANISM(S) OF SUPPORT This PA uses the NIH Research Project Grant (R01), Exploratory/Developmental Grant (R21), Clinical Trial Planning Grant (R34), and Small Grant (R03) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an R01 application submitted in response to this PA may not exceed five years. The Small Grant (R03) provides two years of funding with a maximum of $50,000 direct costs for each year. Instructions for the R03 application can be found at (http://grants.nih.gov/grants/guide/pa-files/PA-03-108.html). The Exploratory/ Developmental Grant (R21) provides two years of funding with a maximum of $275,000 direct costs for each year over the entire budget period; with no one year exceeding $200,000. It is intended for development and pilot testing of novel models and sensitive neurochemical measurements. http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. The R34 mechanism provides up to $450,000 direct costs for three years with no one year exceeding $225,000 for research on 1) the development and/or pilot testing of new or adapted interventions, 2) pilot testing interventions with demonstrated efficacy in broader scale effectiveness trials, or 3) innovative services research directions that require preliminary testing or development. Instructions for R21 applications can be found at (http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html). This PA uses just-in-time concepts. It also uses the modular as well as the non- modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Mary C. Blehar, Ph.D. Director, Women's Mental Health Program National Institute of Mental Health 6001 Executive Boulevard, Room 8125, MSC 9659 Bethesda, MD 20892-9659 Telephone: (301) 443-2847 FAX: (301) 443-8552 Email: mblehar@mail.nih.gov o Direct your questions about financial or grants management matters to: Joy R. Knipple Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-8811 FAX: (301) 443-6885 Email: jk173@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02 -001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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